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Trial Title:
Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer
NCT ID:
NCT06013098
Condition:
Atelectasis, Postoperative
Conditions: Official terms:
Esophageal Neoplasms
Pulmonary Atelectasis
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
30%Oxygen
Description:
60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation
Arm group label:
Experimental: 30% Oxygen
Intervention type:
Drug
Intervention name:
60%Oxygen
Description:
100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation
Arm group label:
Experimental: 60% Oxygen
Summary:
Radical operation of esophageal cancer is complicated and traumatic, and ventilation with
one lung in lateral position and ventilation with both lungs after supine position
requires long-term tracheal intubation and ventilator-assisted ventilation, and the
incidence of postoperative pulmonary complications is high.
Detailed description:
Therefore, we should explore the most appropriate lung protection ventilation strategy to
reduce the occurrence of pulmonary complications. The recommended standard of
international expert group on lung protective ventilation strategy points out that the
lowest concentration of oxygen (≤40%) should be inhaled as much as possible during
mechanical ventilation to maintain normal blood oxygen level (SpO2≥94%). If the mixed gas
with low inhaled oxygen concentration can achieve ideal oxygen saturation and arterial
oxygen partial pressure, it may reduce the postoperative pulmonary complications of the
subjects. However, there are few reports on the influence of different oxygen
concentrations on pulmonary complications in patients undergoing radical resection of
esophageal cancer. This study intends to explore the influence of different oxygen
concentrations on pulmonary complications in patients undergoing radical resection of
esophageal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- American Association of Anesthesiologists (ASA) patients with I-II physical
condition;
- Patients with preoperative partial pressure of blood gas and oxygen greater than
80mmHg who were scheduled for elective esophageal cancer surgery were operated in
the right lateral position first and then in the supine position.
Exclusion Criteria:
- there is a history of acute lung injury with acute respiratory distress syndrome
within three months;
- Heart failure (classified by new york Heart Association) is greater than grade IV,
- there is a serious liver and kidney dysfunction (children with grade B or C liver
failure, glomerular filtration rate < 30 ml/min);
- Body mass index > 30kg/m2；
- coagulation dysfunction;
- Operation time exceeds 10h
- The amount of bleeding is more than 800ml, and the total fluid volume is more than
3000ml.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
the First Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110001
Country:
China
Status:
Recruiting
Contact:
Last name:
Wenfei Tan, M.D.,Ph.D
Phone:
024-83283100
Email:
winfieldtan@hotmail.com
Start date:
September 6, 2023
Completion date:
September 30, 2026
Lead sponsor:
Agency:
China Medical University, China
Agency class:
Other
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06013098
